Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT07128368
Eligibility Criteria:
Inclusion Criteria:
* Sedentary (≤30min of physical activity on ≤1 day/week)
* Weight stable for ≥3 months prior to study
Exclusion Criteria:
* Active coronary artery disease or heart failure.
* Participation in a structured exercise program \> 1 day/week.
* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
* Abnormal liver function test results (Transaminase \>2 times the upper limit of normal)
* Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2); If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
* Uncontrolled thyroid disease (TSH undetectable or \>10 mlU/L); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise
* Abuse of alcohol or recreational drugs
* Active tobacco usage
* Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).
* Uncontrolled arterial hypertension (Resting diastolic blood pressure \>90 mmHg and/or systolic blood pressure \>160 mmHg) at the time of screening.
* A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
* Active pregnancy
* Menopause (defined as absence of menstruation for 12 consecutive months)
* Restrictions on Use of Other Drugs or Treatments:
* Any other medication believed to be a contraindication to the subject's participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT07128368
Study Brief:
Protocol Section:
NCT07128368